目的 系统评估、提炼儿童紫癜性肾炎（HSPN）临床试验设计与评价的技术要素，为儿童HSPN中药临床试验设计的标准化和试验结果的相互比较提供一定的可行性。方法 采用文献研究法，系统检索中国学术期刊全文数据库（CNKI）、万方数据库（Wanfang Data）、中国生物医学文献数据库（SinoMed）、维普生物医学数据库（VIP）、中国临床试验注册中心、PubMed、Cochrane library、Embase、Web of Science、Clinical Trials等数据库和临床试验注册平台，检索时限为建库至2026年3月。结果 初步检索出文献11 639篇，最终纳入33篇，中文28篇，英文5篇。22项定位为临床治疗HSPN，11项定位为预防HSPN。33项研究均采用随机对照原则； 5项为双盲设计； 5项提及样本量估算； 5项为优效性检验，28项为差异性检验。28项有明确的西医诊断标准，21项有明确的中医辨证标准。33项均有明确的纳排标准。干预措施主要包括中药联合化学药16项、中药6项及化学药11项。试验流程，33项均未设置导入期，20项设立随访期；疗程分别为4～24周和5 d～12周。有效性评价，主要疗效指标围绕血尿、蛋白尿及肾损伤疗效和肾损伤发生率定义，21项为疾病综合疗效，1项为中医证候疗效，11项为HSPN发生率。27项以不良事件/不良反应发生率作为安全性评价指标。25项明确要求签署知情同意书，13项明确通过伦理批准。结论 纳入文献虽存在一定的方法学缺陷，但信息较完善，结果涵盖了中医药防治儿童HSPN临床试验设计与评价的基本技术要素，对临床试验设计具有一定的参考价值和借鉴意义，为指南的制定提供证据支撑。

Objective To systematically evaluate and distill the technical elements of clinical trial design and evaluation for HenochSch?nlein purpura nephritis (HSPN) in children, providing a certain feasibility for the standardization of clinical trial design and the comparison of trial results of traditional Chinese medicine (TCM) for pediatric HSPN. Methods A literature research approach was adopted. A systematic search was conducted in databases and clinical trial registration platforms including China National Knowledge Infrastructure (CNKI), Wanfang, VIP, China Biomedical Literature Service System (SinoMed), Chinese Clinical Trial Registry, PubMed, Cochrane Library, Embase, Web of Science, and Clinical Trials from the establishment of the databases to March 2026. Results A total of 11 639 documents were initially retrieved, and 33 were finally included, among which 28 were in Chinese and 5 were in English. Among them, 22 were focused on the clinical treatment of HSPN, and 11 were on the prevention of HSPN. All 33 studies adopted the principle of random control, five were double-blind designs, five mentioned sample size estimation, five were superiority tests, and 28 were difference tests. 28 had clear Western medical diagnostic criteria, and 21 had clear TCM syndrome differentiation criteria. All 33 studies had clear inclusion and exclusion criteria. The intervention measures mainly included 16 studies of TCM combined with western medicine, six studies of TCM, and 11 studies of Western medicine. Regarding the trial process, none of the 33 studies set an induction period, and 20 studies had a follow-up period. The treatment courses were 4 to 24 weeks and 5 d to 12 weeks. For the evaluation of effectiveness, the main efficacy indicators were defined around the therapeutic effects of hematuria, proteinuria, and renal injury, and the incidence of renal injury. A total of 21 studies focused on the comprehensive therapeutic effect of the disease, 1 on the therapeutic effect of TCM syndromes, and 11 on the incidence of HSPN. A total of 27 studies used the incidence of adverse events/adverse reactions as the safety evaluation index. A total of 25 studies clearly required the signing of informed consent forms, and 13 studies clearly obtained ethical approval. Conclusion Although the included literature has certain methodological flaws, the information is relatively complete. The results cover the basic technical elements of the design and evaluation of clinical trials on the prevention and treatment of HSPN in children with traditional Chinese medicine, which has certain reference value and significance for the design of clinical trials and provides evidence support for the formulation of guidelines.

R983

国家自然科学基金资助项目（82374519）；河南省科技攻关项目（262102311127）；中华中医药学会标准化项目（20240110-BZ-CACM）；河南省中医药科研专项课题（2025ZY3008、LHGJ20250419）；河南中医药大学第一附属医院博士科研启动基金项目（2024BSII008）